AdrenoMed AG

About AdrenoMed AG

AdrenoMed AG is a German privately financed, clinical-stage biopharmaceutical company developing a precision medicine treatment for septic shock. Founded in 2009 and based in Hennigsdorf near Berlin, its mission is to rescue vascular integrity in order to save the lives of critically ill patients with limited treatment options.

Sepsis accounts for an estimated 49 million cases and 11 million deaths worldwide each year, close to one in five of all deaths. Septic shock, its most severe form, continues to carry high mortality despite best supportive care, and no targeted pharmacological therapy has ever been approved. Four decades of failed trials share a common cause: sepsis is not a single disease, and studies that enrol every patient meeting the syndrome definition dilute a real treatment effect across a population in which most patients were never going to respond.

AdrenoMed's lead candidate, enibarcimab (formerly adrecizumab), is a first-in-class humanised, non-neutralising monoclonal antibody targeting adrenomedullin (ADM), the hormone that governs vascular barrier function. Rather than blocking ADM, enibarcimab binds it in a way that retains it in the bloodstream, where it is protective, and limits its movement into the interstitial space, where it drives the vascular leak and refractory hypotension that define shock. The mechanism is therefore to restore the endothelial barrier rather than to suppress inflammation, the approach that has repeatedly failed in this indication.

That mechanism is paired with a biomarker-guided patient selection strategy built on two markers. Bio-ADM identifies loss of vascular integrity, and so the patients who have the pathology the drug addresses. DPP3 identifies patients whose organ dysfunction is driven by a different mechanism and who are unlikely to benefit. Used together, they define a treatable population rather than an average across a heterogeneous syndrome, and the same markers are intended to guide use in clinical practice after approval.

Enibarcimab has completed AdrenOSS-2, a randomised, double-blind, placebo-controlled, multicentre Phase 2 proof-of-concept study in 301 patients with septic shock, enriched for elevated bio-ADM resulting in a significant 67% relative reduction in 28 day all cause mortality. The programme holds US FDA Fast Track designation for the treatment of septic shock, granted in 2024.

AdrenoMed has received positive feedback from both the FDA and the EMA and is aligned with both agencies on a single pivotal Phase 3 registration study, with 28-day all-cause mortality as the primary endpoint, designed to support marketing applications in the United States and the European Union. Preparation of that study is well advanced, and its initiation is tied to completion of the company's current financing round.

The company is backed by an institutional investor base including Wellington Partners and HBM Healthcare Investments, and has raised equity across Series A to Series E, including a EUR 24 million Series D in 2018 and a EUR 22.2 million Series E in 2020.